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Cluster HeadacheDETECTNCT05857098

Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients

An observational study of Cluster Headache and Trigeminal Autonomic Cephalgia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Local Field potential recording
How many people
5 participants
Where
1 siteFrance
Study dates
31 May 2023to 1 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Adult, Older adult

Study population: Patients suffering from refractry chronic cluster headache

Who may be able to join

  • Adult patients (age : 18-70 years-old) suffering from refractory chronic cluster headache
  • Patients eligible for a deep brain stimulation in the ventral tegmental area of the mesencephalon
  • Patients implanted with a deep brain stimulation system PerceptTM Medtronic®

Who cannot join

  • Secondary cluster headache
  • Patients implanted with another device of deep brain stimulation

Trial locations and contacts

1 site in 1 country.

France1 site
  • Assistance Publique Hopitaux de Marseille

    Marseille

    Anne BALOSSIER, MD

Other trials in France

About this study

Official title: Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients Treated by Deep Brain Stimulation : a Feasibility Study

The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. There are many clinical arguments in favor of the involvement of the hypothalamus in CH. In addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. Thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. Voxel based MRI studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. The involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised.

Deep brain stimulation (dBS) is used in the management of chronic drug-resistant CH with an overall efficacy in 2/3 of patients. Nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. The lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dBS electrodes and parameters adjustment. In order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. Local fields potentials (LFP) have been recordered by in vivo by dBS in other diseases (Parkinson's disease, tremor…) and their analysis has brought new insigights in the characterization and understanding of these pathology. New generations of neurostimulator (Percept Medtronic) enables continuous recording of LFP in implanted patients. The goal of our study is the recording of LFP at the time of CH attacks via the BrainSenseTM system. This system included in the stimulator allows in vivo collection of LFP in the absence and presence of stimulation. The pathophysiological data recordered will then be correlated with the clinical benefit of the dBS ( nulber of attacks, duration, pain intensity…). As it is a feasibility study, only 5 patients will be included.

Being tested
Local Field potential recording
Keywords
Hypothalamus, Local Fields Potentials
Medical subject headings
Cluster Headache, Trigeminal Autonomic Cephalalgias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local Field potential recordingOther

    Continuous recording of Local Field potentials in patients implanted with Deep brain stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Local field potentials

    Local field potentials amplitudes registered by the patient during a cluster attack

    Measured: Between 0 to 12 months

Secondary outcomes (4)
  1. Change in Efficacy of deep brain stimulation on attacks frequency

    Frequency of cluster attacks

    Measured: Between 0 to 12 months

  2. Change in Efficacy of deep brain stimulation on pain intensity

    Pain intensity of cluster attacks

    Measured: Between 0 to 12 months

  3. Change Efficacy of deep brain stimulation in attacks duration

    Duration of cluster attacks

    Measured: Between 0 to 12 months

  4. Change in Efficacy of deep brain stimulation on treatment

    Medical treatments for cluster headache

    Measured: Between 0 to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start31 May 2023 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05857098
Sponsor's protocol ID
RCAPHM23_0056
Acronym
DETECT
Status last verified
Apr 2023
First submitted
5 Apr 2023
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cluster Headache and Trigeminal Autonomic Cephalgia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anne BALOSSIER, MD (0491384277 ext. +33, anne.balossier@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Local field potentials (time frame: Between 0 to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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